JEVTANA® (cabazitaxel) injection logo

Menu

The CARD Trial Was the First Comparative, Prospective, Phase 4 Trial Evaluating JEVTANA® (cabazitaxel) injection vs Abiraterone or Enzalutamide1,2


   

Randomized, Open-Label, Multicenter Trial (N=255)

  • The trial enrolled patients with mCRPC who previously received docetaxel and progressed within 12 months on abiraterone or enzalutamide

  • Conducted at 62 sites in 13 European countries

Endpoints

  • Primary endpoint: rPFS*

  • Other efficacy outcomes included OS, tumor response, and safety
N=255

Patients with mCRPC who had previously received docetaxel (at least 3 cycles before or after abiraterone or enzalutamide) and had disease progression within 12 months on abiraterone or enzalutamide

DOCE     ►     ASTI     OR     ASTI     ►     DOCE

Stratification:

ECOG PS: 0,1 vs 2

Time to disease progression (<6 months vs >6 to 12 months)

Timing of previous treatment with abiraterone or enzalutamide (before vs after docetaxel)

Randomized 1:1JEVTANA 25 mg/m2
q3w + oral prednisone 10 mg daily + G-CSF (n=129)
Oral abiraterone 1000 mg once daily + oral prednisone 5 mg twice daily OR oral enzalutamide 160 mg once daily (n=126)

Median follow-up was 9.2 months from randomization until the end of the study.2
ASTI=androgen-signaling-targeted inhibitor (abiraterone or enzalutamide); CT=computed tomography; DOCE=docetaxel; ECOG PS=Eastern Cooperative Oncology Group performance status; G-CSF=granulocyte-colony stimulating factor; mCRPC=metastatic castration-resistant prostate cancer; MRI=magnetic resonance imaging; OS=overall survival; PCWG2=Prostate Cancer Clinical Trials Working Group 2; q3w=every 3 weeks; RECIST=Response Evaluation Criteria in Solid Tumors; rPFS=radiographic progression-free survival.
*rPFS is defined as the time from randomization to the occurrence of one of the following events: radiological tumor progression using RECIST 1.1 (except for lymph nodes: if lymph node metastasis is the only evidence of metastasis at baseline, it must be ≥20 mm in diameter when measured by spiral CT or MRI [as defined by PCWG2]), progression of bone lesions according to PCWG2 criteria, or death.3
Patients had histologically confirmed prostate cancer and castrate levels of serum testosterone (<0.5 ng/mL).2
Abiraterone was given to patients who had previously received enzalutamide before trial entry and enzalutamide was given to patients who had previously received abiraterone.2

Identify Appropriate Patients for JEVTANA in Your Practice

JEVTANA Was Studied in a Broad and Diverse Population, Including Patients With High Disease Burden1

CARD Trial Included Patients With High Disease Burden4

Image listing: 7% lung, 11% liver, 59% bone, 5% lymph nodes.

Summary of Demographic and Patient Characteristics at Baseline2,4

 

JEVTANA 25 mg/m2
+ prednisone (n=129)

abiraterone or
enzalutamide (n=126)

Age, yearsMedian (range)70 (46-85)71 (45-88)
≥75, No. (%)45 (34.9)4 (27.0)
ECOG PS, No. (%)0,1123 (95.3)119 (94.4)
26 (4.7)7 (5.6)
Disease site, No. (%)Bone (± lymph nodes)74 (57.4)76 (60.3)
Lymph nodes8 (6.2)6 (4.8)
Liver11 (8.5)18 (14.3)
Lung10 (7.8)7 (5.6)
PSA, ng/mLMedian (range)62.0 (1.1-15,000.0)60.5 (1.5-2868.0)
Type of progression at trial
entry, No. (%)
PSA only11 (8.5)10 (7.9)
Imaging-based, with or
without PSA progression
23 (17.8)16 (12.7)
Pain, with or without PSA or
imaging-based progression
86 (66.7)90 (71.4)
Missing data9 (7.0)10 (7.9)

Disease History

M1 disease at diagnosis, No. (%)49 (38.0)60 (47.6)
Gleason score 8-10 at diagnosis, No. (%)73 (56.6)81 (64.3)
First androgen deprivation
therapy
Median duration,
months (range)
13.7 (2-114)12.6 (3-179)
Previous ASTI, No. (%)§Abiraterone56 (43.4)67 (53.2)
Enzalutamide72 (55.8)59 (46.8)
Timing of previous ASTI, No.
(%)
Before docetaxel50 (38.8)49 (38.9)
After docetaxel79 (61.2)77 (61.1)

M1 disease=metastatic disease (distant metastases); PSA=prostate-specific antigen.
§One patient (0.8%) had missing data in the JEVTANA group. 

Explore results that may change
how you see JEVTANA

Learn about the study that
validated JEVTANA as a 2nd-line
treatment after docetaxel

Important Safety Information

WARNING: NEUTROPENIA AND HYPERSENSITIVITY
Neutropenia: Neutropenic deaths have been reported. Monitor for neutropenia with frequent blood cell counts. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm3. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m2.

Severe hypersensitivity: Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the JEVTANA infusion and administration of appropriate therapy. Patients should receive premedication. JEVTANA is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80.

Contraindications

JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500/mm3, patients with a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80, and patients with severe hepatic impairment (total bilirubin >3x upper limit of normal (ULN)).

Warnings and Precautions

Bone Marrow Suppression (BMS): BMS manifested as neutropenia, anemia, thrombocytopenia and/or pancytopenia may occur. Neutropenic deaths have been reported. Monitor blood counts frequently to determine if initiation of G-CSF and/or dosage modification is needed. Monitoring of complete blood counts is essential on a weekly basis during cycle 1 and before each treatment cycle thereafter so that the dose can be adjusted, if needed. Caution is recommended in patients with hemoglobin < 10 g/dl.

Increased Toxicities in Elderly Patients: Patients ≥65 years of age were more likely to experience fatal outcomes not related to disease progression and certain adverse reactions, including neutropenia and febrile neutropenia. Monitor closely.

Hypersensitivity Reactions: Severe hypersensitivity reactions can occur. Premedicate all patients with antihistamines, corticosteroids and H2 antagonists prior to JEVTANA. Observe patients closely, especially during the first and second infusions. Discontinue JEVTANA immediately if severe hypersensitivity occurs and treat as indicated.

Gastrointestinal (GI) Adverse Reactions: Nausea, vomiting, and severe diarrhea may occur. Death related to diarrhea and electrolyte imbalance occurred in the randomized clinical trials and mortality related to diarrhea has been reported. Intensive measures may be required for severe diarrhea and electrolyte imbalance. Rehydrate and treat with antiemetics and antidiarrheals as needed. If experiencing grade ≥3 diarrhea, dosage should be modified.

GI hemorrhage and perforation, ileus, enterocolitis, neutropenic enterocolitis, including fatal outcome, have been reported. Risk may be increased with neutropenia, age, steroid use, concomitant use of NSAIDs, antiplatelet therapy or anticoagulants, and prior history of pelvic radiotherapy, adhesions, ulceration and GI bleeding. Abdominal pain and tenderness, fever, persistent constipation, diarrhea, with or without neutropenia, may be early manifestations of serious GI toxicity and should be evaluated and treated promptly. JEVTANA treatment delay or discontinuation may be necessary.

Renal Failure: Cases, including those with fatal outcomes, have been reported. Identify cause and manage aggressively.

Urinary Disorders including Cystitis: Cystitis, radiation cystitis, and hematuria, including that requiring hospitalization, has been reported with JEVTANA in patients who previously received pelvic radiation. Cystitis from radiation recall may occur late in treatment with JEVTANA. Monitor patients who previously received pelvic radiation for signs and symptoms of cystitis while on JEVTANA. Interrupt or discontinue JEVTANA in patients experiencing severe hemorrhagic cystitis. Medical and/or surgical supportive treatment may be required to treat severe hemorrhagic cystitis.

Respiratory Disorders: Interstitial pneumonia/pneumonitis, interstitial lung disease and acute respiratory distress syndrome have been reported and may be associated with fatal outcome. Patients with underlying lung disease may be at higher risk for these events. Acute respiratory distress syndrome may occur in the setting of infection. Interrupt JEVTANA if new or worsening pulmonary symptoms develop. Closely monitor, promptly investigate, and appropriately treat patients receiving JEVTANA. Consider discontinuation. The benefit of resuming JEVTANA treatment must be carefully evaluated.

Use in Patients with Hepatic Impairment: JEVTANA dose should be reduced for patients with mild (total bilirubin > 1 to ≤ 1.5 x ULN or AST > 1.5 x ULN) and moderate (total bilirubin > 1.5 to ≤ 3.0 x ULN and any AST) hepatic impairment, based on tolerability data in these patients. Administer JEVTANA 20 mg/m2 for mild hepatic impairment. Administer JEVTANA 15 mg/m2 for moderate hepatic impairment. Monitor closely.

Embryo-Fetal Toxicity: JEVTANA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of JEVTANA.

Adverse Reactions (ARs)

The most common all grades adverse reactions and laboratory abnormalities (≥10%) with JEVTANA 20 mg/m2 or 25 mg/m2 are neutropenia, anemia, diarrhea, nausea, fatigue, asthenia, vomiting, hematuria, constipation, decreased appetite, back pain, and abdominal pain.

Drug Interactions

Avoid coadministration of JEVTANA with strong CYP3A inhibitors. If patients require coadministration of a strong CYP3A inhibitor, consider a 25% JEVTANA dose reduction.

Use in Specific Populations

  • Pregnancy: The safety and efficacy of JEVTANA have not been established in females. There are no human data on the use of JEVTANA in pregnant women to inform the drug-associated risk.
  • Lactation: The safety and efficacy of JEVTANA have not been established in females. There is no information available on the presence of JEVTANA in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.
  • Females and Males of Reproductive Potential: Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of JEVTANA.

Indication

JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing treatment regimen.

Important Safety Information

Indication

References: 1. JEVTANA Prescribing Information. Bridgewater, NJ: sanofi-aventis U.S. LLC. 2. de Wit R, de Bono J, Sternberg CN, et al; for the CARD Investigators. Cabazitaxel versus abiraterone or enzalutamide in metastatic prostate cancer. N Engl J Med. 2019;381(26):2506-2518. 3. Data on file. Bridgewater, NJ: sanofi-aventis U.S. LLC. 4. Supplement to: de Wit R, de Bono J, Sternberg CN, et al; for the CARD Investigators. Cabazitaxel versus abiraterone or enzalutamide in metastatic prostate cancer. N Engl J Med. 2019;381(26):2506-2518.

JEVTANA and Sanofi are registered trademarks of Sanofi or an affiliate. All other trademarks are the property of their respective owners. MAT-US-2308148-v2.0-02/2025